Use of Left Ventricular Assist Devices As Destination Therapy in End-Stage Congestive Heart Failure: a Systematic Review
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Department of Veterans Affairs Health Services Research & Development Service Evidence-based Synthesis Program Use of Left Ventricular Assist Devices as Destination Therapy in End-Stage Congestive Heart Failure: A Systematic Review May 2012 Prepared for: Investigators: Department of Veterans Affairs Principal Investigators: Veterans Health Administration Thomas S. Rector, Ph.D. Quality Enhancement Research Initiative Brent C. Taylor, Ph.D., M.P.H. Health Services Research & Development Service Washington, DC 20420 Research Associates: Nancy Greer, Ph.D. Prepared by: Indulis Rutks, B.S. Evidence-based Synthesis Program (ESP) Center Minneapolis VA Medical Center Minneapolis, MN Timothy J. Wilt, M.D., M.P.H., Director Use of Left Ventricular Assist Devices as Destination Therapy in End-Stage Congestive Heart Failure: A Systematic Review Evidence-based Synthesis Program PREFACE Quality Enhancement Research Initiative’s (QUERI) Evidence-based Synthesis Program (ESP) was established to provide timely and accurate syntheses of targeted healthcare topics of particular importance to Veterans Affairs (VA) managers and policymakers, as they work to improve the health and healthcare of Veterans. The ESP disseminates these reports throughout VA. QUERI provides funding for four ESP Centers and each Center has an active VA affiliation. The ESP Centers generate evidence syntheses on important clinical practice topics, and these reports help: • develop clinical policies informed by evidence, • guide the implementation of effective services to improve patient outcomes and to support VA clinical practice guidelines and performance measures, and • set the direction for future research to address gaps in clinical knowledge. In 2009, the ESP Coordinating Center was created to expand the capacity of QUERI Central Office and the four ESP sites by developing and maintaining program processes. In addition, the Center established a Steering Committee comprised of QUERI field-based investigators, VA Patient Care Services, Office of Quality and Performance, and Veterans Integrated Service Networks (VISN) Clinical Management Officers. The Steering Committee provides program oversight, guides strategic planning, coordinates dissemination activities, and develops collaborations with VA leadership to identify new ESP topics of importance to Veterans and the VA healthcare system. Comments on this evidence report are welcome and can be sent to Nicole Floyd, ESP Coordinating Center Program Manager, at [email protected]. Recommended citation: Rector TS, Taylor BC, Greer N, Rutks I, and Wilt TJ. Use of Left Ventricular Assist Devices as Destination Therapy in End-Stage Congestive Heart Failure: A Systematic Review. VA-ESP Project #09-009; 2012. This report is based on research conducted by the Evidence-based Synthesis Program (ESP) Center located at the Minneapolis VA Medical Center, Minneapolis, MN funded by the Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development, Quality Enhancement Research Initiative. The findings and conclusions in this document are those of the author(s) who are responsible for its contents; the findings and conclusions do not necessarily represent the views of the Department of Veterans Affairs or the United States government. Therefore, no statement in this article should be construed as an official position of the Department of Veterans Affairs. No investigators have any affiliations or financial involvement (e.g., employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties) that conflict with material presented in the report. i Use of Left Ventricular Assist Devices as Destination Therapy in End-Stage Congestive Heart Failure: A Systematic Review Evidence-based Synthesis Program TABLE OF CONTENTS EXECUTIVE SUMMARY Background .................................................................................................................................................... 1 Methods ......................................................................................................................................................... 1 Data Synthesis ............................................................................................................................................... 2 Peer Review ................................................................................................................................................... 2 Results ........................................................................................................................................................... 2 Recommendations for Future Research ......................................................................................................... 4 INTRODUCTION ............................................................................................................................................... 5 Ventricular Assist Devices Approved for Use as Destination Therapy ......................................................... 6 Centers for Medicare and Medicaid Services (CMS) Coverage ................................................................... 6 Registry of Ventricular Assist Devices Used as Destination Therapy ........................................................... 7 Guideline Recommendations ......................................................................................................................... 7 METHODS Topic Development ........................................................................................................................................ 9 Search Strategy .............................................................................................................................................. 9 Study Selection ............................................................................................................................................ 10 Data Abstraction .......................................................................................................................................... 12 Quality Assessment ..................................................................................................................................... 12 Rating the Body of Evidence ....................................................................................................................... 13 Data Synthesis ............................................................................................................................................. 14 Peer Review ................................................................................................................................................. 14 RESULTS Literature Search ......................................................................................................................................... 15 Key Question #1. How does use of an FDA-approved, current generation LVAD as destination therapy (i.e., the HeartMate II left ventricular assist device) effect patient outcomes? .............................. 15 Key Question #2. What patient or site characteristics have been associated with patient benefits or harms when the FDA-approved, current generation LVAD is used as destination therapy? .................. 17 Key Question #3. What is the range of cost-effectiveness estimates of using the FDA-approved, current generation LVAD as destination therapy in end-stage heart failure and what explains variation in these estimates? ........................................................................................................................ 19 SUMMARY AND DISCUSSION Summary Points ........................................................................................................................................... 21 Limitations ................................................................................................................................................... 21 Recommendations for Future Research ....................................................................................................... 21 Conclusions ................................................................................................................................................. 23 REFERENCES ................................................................................................................................................... 24 ii Use of Left Ventricular Assist Devices as Destination Therapy in End-Stage Congestive Heart Failure: A Systematic Review Evidence-based Synthesis Program FIGURES Figure 1. Analytic Framework ................................................................................................................. 10 Figure 2. Literature Flow Diagram .......................................................................................................... 15 APPENDIX A. Technical Expert Panel Mem B ers ............................................................................ 27 APPENDIX B. Search Strategy ............................................................................................................... 28 APPENDIX C. Peer Revie W Comments /Author Responses .......................................................... 29 APPENDIX D. Evidence TA B les Table 1. Key Question #1: Effects on Patient Outcomes ...................................................................... 34 Table 2. Key Question #2: Patient Selection ........................................................................................